Table 4. Summary of secondary efficacious end-points.
| End-points | Change from baseline to follow-up | Placebo-OM-85 difference (95% CI) | P value | |
|---|---|---|---|---|
| OM-85 BV | Placebo | |||
| Follow-up after 6 months | ||||
| Leicester scores | 1.61 | 2.51 | 0.90 (−2.02, 3.82) | 0.525 |
| St. George scores | −7.94 | −6.56 | 1.38 (−8.95, 11.70) | 0.785 |
| Lung functions measures (pre-bronchodilator) | ||||
| FEV1/pred (%) | 0.67 | 0.55 | −0.12 (−2.33, 2.10) | 0.918 |
| FVC/pred (%) | −3.42 | 0.61 | 4.03 (−5.45, 13.52) | 0.401 |
| FEV1/FVC (%) | −0.66 | −0.83 | −0.17 (−1.99, 1.66) | 0.859 |
| Blood tests | ||||
| White cells counting (109/L) | −0.07 | −0.17 | −0.10 (−0.67, 0.47) | 0.729 |
| Neutrophil (%) | −0.04 | −1.75 | −1.71 (−4.40, 0.98) | 0.212 |
| CRP (mg/L) | −5.01 | −0.96 | 4.05 (−2.61, 10.71) | 0.231 |
| ESR (mm/h) | −2.48 | −3.21 | −0.73 (−5.51, 4.05) | 0.763 |
| Follow-up after 12 months | ||||
| Leicester score | 3.58 | 2.08 | −1.50 (−5.42, 2.42) | 0.430 |
| St. George’s Respiratory Questionnaire score | −12.29 | −11.75 | −0.54 (−12.40, 11.32) | 0.925 |
| Lung function measures (before bronchodilator) | ||||
| FEV1/pred (%) | 1.15 | −0.12 | −1.27 (−4.22, 1.69) | 0.398 |
| FVC/pred (%) | −2.75 | 0.91 | 3.66 (−7.18, 14.49) | 0.504 |
| FEV1/FVC (%) | −0.73 | −1.44 | −0.71 (−3.29, 1.88) | 0.590 |
| Blood tests | ||||
| White cells counting (109/L) | 0.08 | −0.08 | −0.16 (−0.95, 0.62) | 0.676 |
| Neutrophil (%) | −1.02 | −2.54 | −1.52 (−4.96, 1.92) | 0.385 |
| CRP (mg/L) | −1.34 | −3.13 | −1.79 (−9.02, 5.43) | 0.625 |
| ESR (mm/h) | −4.36 | −7.98 | −3.62 (−9.49, 2.25) | 0.225 |
CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; FEV1/pred, forced expiratory volume in first second/predicated; FVC/pred, forced vital capacity/predicated; CI, confidence interval.